Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Music to Reduce Pain and Anxiety in the Pediatric Emergency Department

This study has been completed.
Sponsor:
Collaborator:
Stollery Children's Hospital Foundation
Information provided by:
University of Alberta
ClinicalTrials.gov Identifier:
NCT00761033
First received: September 25, 2008
Last updated: April 16, 2010
Last verified: April 2010

September 25, 2008
April 16, 2010
October 2008
Not Provided
Observation Scale of Behavioral Distress-Revised (OSBD-R) [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00761033 on ClinicalTrials.gov Archive Site
Pain [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Music to Reduce Pain and Anxiety in the Pediatric Emergency Department
Music to Reduce Pain and Anxiety in the Pediatric Emergency Department: a Randomized Controlled Trial of Children 3-6 Years Undergoing Intravenous Placement

Many medical procedures aimed at helping children can cause them pain and distress. If children experience certain levels of pain or distress, it can have long lasting negative effects. The emergency department can be a particularly stressful place for children and their parents. There are also many procedures that children may have in the emergency department that can cause pain and distress. These include procedures such as needle pokes, stitches, or setting a broken bone. Two common methods of managing a child's pain in the emergency department are drugs and distraction. Drugs are not always practical and may come with unwanted side effects. Distraction is often used formally or informally and by parents or the health professionals. One form of distraction involves listening to music. This can lower the child's pain and distress by moving their attention from the painful stimulus, for example a needle poke, to a more pleasant sensation such as familiar children's songs. This study will test whether music is useful to help lower pain and distress for young children (ages 3 to 6 years) who are visiting an emergency department and need an intravenous line. Music is safe and pleasant for children. The results from this study could be important for many children receiving medical care.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Pain
  • Distress
Behavioral: music
  • Experimental: music
    children will listen to music during procedure
    Intervention: Behavioral: music
  • Standard care
    Standard care
    Intervention: Behavioral: music
Hartling L, Newton AS, Liang Y, Jou H, Hewson K, Klassen TP, Curtis S. Music to reduce pain and distress in the pediatric emergency department: a randomized clinical trial. JAMA Pediatr. 2013 Sep;167(9):826-35. doi: 10.1001/jamapediatrics.2013.200.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
Not Provided
Not Provided

Inclusion Criteria:

  • Children attending the pediatric ED between the ages of 3 and 6 years - Undergoing an IV placement
  • Conscious
  • Have sufficient knowledge of the English language to understand and follow instructions and complete the age-appropriate pain assessment

Exclusion Criteria:

  • Children with hearing impairments, developmental disabilities, or sensory impairment to pain (e.g., spina bifida)
  • Children will be excluded at the discretion of the attending staff (e.g., child in critical condition; requires urgent IV placement; or has altered level of consciousness).
Both
3 Years to 6 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00761033
B-010908
No
Lisa Hartling/Assistant Professor, University of Alberta
University of Alberta
Stollery Children's Hospital Foundation
Not Provided
University of Alberta
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP